Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)
2 other identifiers
interventional
273
1 country
1
Brief Summary
The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv
Started Jun 2003
Longer than P75 for phase_2 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedOctober 6, 2008
October 1, 2008
4.9 years
December 9, 2005
October 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
How to best help people with serious mental illness follow HIV treatment regimens
baseline, 3, 12 and 24 months
Study Arms (2)
1 - Experimental
EXPERIMENTAL2 - Control
NO INTERVENTIONInterventions
Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.
Eligibility Criteria
You may qualify if:
- Diagnosis of serious mental illness; HIV positive
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Mental Health Services and Policy Research
Philadelphia, Pennsylvania, 19104, United States
Related Publications (3)
Dalseth N, Reed RS, Hennessy M, Eisenberg MM, Blank MB. Does Diagnosis Make a Difference? Estimating the Impact of an HIV Medication Adherence Intervention for Persons with Serious Mental Illness. AIDS Behav. 2018 Jan;22(1):265-275. doi: 10.1007/s10461-017-1795-5.
PMID: 28536741DERIVEDWu ES, Rothbard A, Holtgrave DR, Blank MB. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV. Community Ment Health J. 2016 May;52(4):439-45. doi: 10.1007/s10597-014-9788-6. Epub 2014 Dec 23.
PMID: 25535041DERIVEDBlank MB, Hennessy M, Eisenberg MM. Increasing quality of life and reducing HIV burden: the PATH+ intervention. AIDS Behav. 2014 Apr;18(4):716-25. doi: 10.1007/s10461-013-0606-x.
PMID: 24000053DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Blank, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 13, 2005
Study Start
June 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
October 6, 2008
Record last verified: 2008-10